Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

Sponsor

George Washington University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04282915

Collaborator

Duke University (Other), Transcultural Psychosocial Organization Nepal (Other), King's College London (Other)

1,300

Enrollment

Location

Arms

33.3

Anticipated Duration (Months)

39.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A growing number of trials have demonstrated treatment effectiveness for mental illness by non-specialist providers, such as primary care providers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against people with mental illness. Therefore, interventions are needed to address attitudes among non- specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE), is an intervention for non-specialists in which social contact with persons with mental illness is added to training and supervision programs. A cluster randomized control trial will address primary objectives including changes in stigma (Social Distance Scale) and improved quality of mental health services, operationalized as accuracy of identifying patients with mental illness in primary care. The control condition is existing mental health training and supervision for non-specialists delivered through the Nepal Ministry of Health's adaptation of the World Health Organization mental health Gap Action Programme. The intervention condition will incorporate social contact with people with mental illness into existing training and supervision. Participants in the cluster randomized control trial will be the direct beneficiaries of training and supervision (primary care providers) and indirect beneficiaries (their patients). Primary care workers' outcomes include stigma (Social Distance Scale), knowledge (mental health Gap Action Programme knowledge scale), implicit attitudes (Implicit Association Test), clinical self-efficacy (mental health Gap Action Programme knowledge scale), and clinical competence (Enhancing Assessment of Common Therapeutic factors) to be assessed pre-training, post-training, and at 3- and 6-month follow-up. Accuracy of diagnoses will be determined through the Structured Clinical Interview for the Diagnostic and Statistical Manual version 5, which will be assessed at 3 months after patient enrollment. Patient outcomes include functioning, quality of life, psychiatric symptoms, medication side effects, barriers to care, and cost of care assessed at enrollment and 3 and 6 months. This study will inform decisions regarding inclusion of persons living with mental illness in training primary care providers.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorder Depressive Disorder Anxiety Disorder Alcohol Use Disorder Psychotic Disorders	Other: Reducing Stigma among Healthcare Providers (RESHAPE) Other: mental health Gap Action Programme	N/A

Detailed Description

There continues to be a major gap between the global burden of persons with mental illness and the number of patients receiving adequate treatment. In the U.S. and other high-income countries, approximately 1 out of 5 persons receives minimally adequate care. In lower-middle income countries, it ranges from 1 out of 27 to 1 out of 100 persons. To address this gap in low- and middle-income countries, a key strategy has been the use of primary care health workers to detect and deliver of care for mental illness. The World Health Organization has developed the mental health Gap Action Programme to train primary care workers to detect mental illness and deliver evidence-supported treatment. However, research to date suggests that implementation strategies for mental health Gap Action Programme are inadequate as evidenced by low detection rates. In Nepal, fewer than half of persons with mental illness were correctly identified by mental health Gap Action Programme-trained primary care workers. A potential barrier to effective implementation of primary care detection is stigma among primary care workers against persons with mental illness.

Our preliminary work suggests that reducing primary care workers' stigma against persons with mental illness may improve accurate detection of mental illness. A version of the mental health Gap Action Programme training that includes a stigma reduction component was developed: REducing Stigma among HealthcAre ProvidErs (RESHAPE). In RESHAPE, persons with mental illness (i.e., service users) are trained to share recovery stories, conduct myth-busting sessions, and promote mental health advocacy. A pilot cluster randomized controlled trial was conducted in Nepal comparing standard mental health Gap Action Programme training delivered psychiatrists and psychosocial specialists with a mental health Gap Action Programme training delivered by both specialists and service users (RESHAPE). Consistent with high-income country literature demonstrating that interaction with service users reduces stigma more effectively that only providing knowledge, stigma was lower among the RESHAPE- arm trained health workers. The pilot results also suggest that reducing stigma may improve detection of mental illness. Therefore, involvement of mental health service users in training primary care workers may reduce stigma, and that stigma reduction may mediate improved detection of mental illness. If these findings are confirmed in an appropriately powered cluster randomized controlled trial, this service user collaborative implementation strategy could make a major contribution to improving primary care detection in low- and middle-income countries, as well as in the U.S. A hybrid implementation-effectiveness (type-3) cluster randomized controlled trial will be in Nepal comparing mental health Gap Action Programme standard implementation with the RESHAPE implementation strategy. Our team of U.S. and Nepali researchers, in partnership with the Nepal Ministry of Health, demonstrated the feasibility of the cluster randomized controlled trial design and identified strategies for cost effectiveness modeling. Target conditions will be depressive disorder, psychotic disorders, and alcohol use disorder.

Aim 1 - To evaluate the impact of the RESHAPE service user engagement on stigma among primary care workers. Hypothesis: Primary care workers in the RESHAPE arm will have less stigma toward persons with mental illness (measured with the Social Distance Scale) 3 months after training compared with primary care workers in the standard training.

Aim 2 - To evaluate the impact of the RESHAPE training on accuracy (sensitivity and specificity) of detection, as measured by the proportion of true positive and true negative diagnoses among patients presenting to primary care facilities, as confirmed by a psychiatrist's structured clinical interview; and to evaluate stigma as a mediator of differences in accuracy. Hypothesis: Primary care workers in the RESHAPE arm will have greater accuracy of detecting mental illness. Secondary analyses: implementation arm differences in patient quality adjusted life years and cost utility will be evaluated.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a cluster randomized controlled trial with municipalities being the unit of randomization. 24 municipalities will be randomized to either RESHAPE or implementation as usual. Three health facilities in each municipality will participate in the study. All primary care providers with prescribing rights will be trained based on their municipality randomization arm.This is a cluster randomized controlled trial with municipalities being the unit of randomization. 24 municipalities will be randomized to either RESHAPE or implementation as usual. Three health facilities in each municipality will participate in the study. All primary care providers with prescribing rights will be trained based on their municipality randomization arm.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

There are two types of study participants: primary care providers and primary care patients. Based on the municipality of randomization, primary care providers will either participate in RESHAPE training or implementation as usual training. Patients will not be randomized because the health facilities they attend are already assigned to either having the primary care providers trained through RESHAPE or implementation as usual. The providers and patients will be masked to the implementation, i.e., they will not be given information on the differences in the two different implementation strategies. Research assistants and research psychiatrists who conduct the assessments will be masked to whether the provider or patients are in the RESHAPE or implementation-as-usual arms.

Primary Purpose:

Health Services Research

Official Title:

Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)

Actual Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Implementation as Usual Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme adapted by the Nepal Ministry of Health.	Other: mental health Gap Action Programme The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.
Experimental: RESHAPE Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme, plus they will have co-facilitation by mental health service users providing recovery testimonials as well as aspirational figures presenting testimonies and conducting myth-busting sessions.	Other: Reducing Stigma among Healthcare Providers (RESHAPE) Mental health service users are trained using Photo Voice to develop recovery story testimonials. They then participate in primary care providers mental health Gap Action Programme training. In addition, aspirational figures are trained to provider testimonials and conduct myth-busting. Other: mental health Gap Action Programme The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.

Arm

Intervention/Treatment

Active Comparator: Implementation as Usual

Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme adapted by the Nepal Ministry of Health.

Other: mental health Gap Action Programme

The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.

Experimental: RESHAPE

Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme, plus they will have co-facilitation by mental health service users providing recovery testimonials as well as aspirational figures presenting testimonies and conducting myth-busting sessions.

Other: Reducing Stigma among Healthcare Providers (RESHAPE)

Mental health service users are trained using Photo Voice to develop recovery story testimonials. They then participate in primary care providers mental health Gap Action Programme training. In addition, aspirational figures are trained to provider testimonials and conduct myth-busting.

Other: mental health Gap Action Programme

Outcome Measures

Primary Outcome Measures

Social Distance Scale (SDS) [6 months post training]
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5) [3-months post-patient enrollment]
Accuracy of clinical diagnosis (this a diagnostic tool, there are no maximum or minimum scores)

Secondary Outcome Measures

mental health Gap Action Programme knowledge test [6 months post-training]
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
mental health Gap Action Programme knowledge test [3 months post-training]
Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome
mental health Gap Action Programme knowledge test [immediately after the training]
Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome
mental health Gap Action Programme self-efficacy assessment [6-months post-training]
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
mental health Gap Action Programme self-efficacy assessment [3-months post-training]
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
mental health Gap Action Programme self-efficacy assessment [immediately after the training]
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
Implicit Association Test [6-months post-training]
Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias
Implicit Association Test [3-months post-training]
Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias
Implicit Association Test [immediately after the training]
Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias
Enhancing Assessment of Common Therapeutic factors [6 months post-training]
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Enhancing Assessment of Common Therapeutic factors [3 months post-training]
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Enhancing Assessment of Common Therapeutic factors [immediately after the training]
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Social Distance Scale [3 months post training]
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Social Distance Scale [immediately after the training]
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Patient: World Health Organization Disability Assessment Scale [6-months post enrollment]
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Patient: World Health Organization Disability Assessment Scale [3-months post enrollment]
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Patient Health Questionnaire 9 [6-months post enrollment]
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Patient Health Questionnaire 9 [3-months post enrollment]
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Patient: Generalized Anxiety Disorder 7 [6 months post enrollment]
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Patient: Generalized Anxiety Disorder 7 [3 months post enrollment]
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Patient: Positive and Negative Symptoms of Schizophrenia [6 months post enrollment]
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Patient: Positive and Negative Symptoms of Schizophrenia [3 months post enrollment]
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Patient: Alcohol Use Disorder Identification Test [6-months post enrollment]
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Patient: Alcohol Use Disorder Identification Test [3-months post enrollment]
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Patient: Euroqol 5 dimension 5 level [6-months post enrollment]
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Patient: Euroqol 5 dimension 5 level [3-months post enrollment]
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Patient: Barriers in Access to Care Evaluation [6-months post-enrollment]
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Patient: Barriers in Access to Care Evaluation [3-months post-enrollment]
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Patient: Cost of Service Receipt Inventory [6-months post-enrollment]
Costs of care to patients, there is no maximum or minimum score, the outcome is total costs
Patient: Cost of Service Receipt Inventory [3-months post-enrollment]
Costs of care to patients, , there is no maximum or minimum score, the outcome is total costs
Patient: Enhancing Assessment of Common Therapeutic factors [6-months post-enrollment]
Common factors use by primary care provider, minimum score = 0, maximum = 15, higher score is better

Other Outcome Measures

Abnormal involuntary movement scale [3-months post-treatment initiation]
Abnormal movements associated with antipsychotic medication, minimum score = 0, maximum score = 40, higher score is worse
Antidepressant side-effect checklist [3-months post-treatment initiation]
Side effects of antidepressant medication, minimum score = 0, maximum score = 63, higher score is worse

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Primary Care Providers

Inclusion Criteria:

All health workers from the facilities included in the study will be invited to participate
Health workers will be between 21 and 65 years of age based on employment criteria
within the government health system.
All participants will need to have Nepali language competency,
be actively engaged in care provision in their health cluster,
have a valid certificate of practice from the Ministry of Health
Health workers will need to have permission from their health supervisor to attend the entire duration of the training,

Exclusion Criteria:

any prior citations on their clinical practice licensure or any other government credentialing violations.

Patients

Inclusion Criteria:

All patients (with non-emergency medical needs) presenting to the primary care
any of the following groups:
(a) any mental illness diagnosis including depression, psychosis (bipolar disorder with a manic episode, schizophrenia, major depressive disorder with psychotic features, and alcohol use disorder with psychosis) and alcohol use disorder; plus the other conditions included in Nepal's mental health Gap Action Programme: anxiety, conversion, epilepsy, dementia, child and adolescent, other substance abuse (these patients are included because misdiagnosis is common with regard to missing or overdiagnosing one condition in place of another mental illness); comorbid conditions are also acceptable;
(b) any patients screening above cut-off scores on the tools; and
(c) 10% of patients who are negative on all of the above criteria.
any patients previously treated for mental illness would be included
age range will be 16 years or older, with no upper age limit (mental health Gap Action Programme training covers child and adolescent through mental illnesses affecting elderly population).
all participants will be able to speak Nepali
able to complete the research interview with the research assistants who will read all of the assessment tools.

Exclusion Criteria:

Patients with immediate medical needs requiring referral and emergency services (e.g., serious injury; pre-eclampsia; dehydration; status epilepticus)
patients needing acute psychiatric services (e.g., suicide attempts, alcohol withdrawal, psychosis/mania that cannot be managed in a community setting) who are referred for immediate hospitalization
Patients under the age of 16 years old will be excluded